PMA P900033S111
- Device
- INTEGRA® Dermal Regeneration Template and Integra® Meshed Dermal Regeneration Template
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P900033
- Supplement
- S111
- Product code
- MGR
- Decision date
- 2024-02-20
- Classification
- General, Plastic Surgery
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- addition of two (2) new Instron model machines at the Collagen Manufacturing Center
Current openFDA PMA Record#
- Device
- INTEGRA® Dermal Regeneration Template and Integra® Meshed Dermal Regeneration Template
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P900033
- Supplement
- S111
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2024-02-20
- Decision code
- OK30
- Date received
- 2024-01-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of two (2) new Instron model machines at the Collagen Manufacturing Center